Durvalumab +/− Lenalidomide for T-Cell Lymphoma

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: City of Hope Medical Center

Must not be taking: Immunotherapy, Immunomodulatory drugs

Disqualifiers: HIV, Hepatitis B/C, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 13

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best dose and assess the side effects of a cancer treatment called durvalumab (Imfinzi), with or without lenalidomide, for T-cell lymphoma. T-cell lymphoma affects the immune system, and this trial targets cases that have returned or do not respond to other treatments. Durvalumab blocks cancer cell growth, while lenalidomide prevents cancer cells from dividing or spreading. Suitable participants have T-cell lymphoma that has not responded to at least two previous treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking therapy.

Do I have to stop taking my current medications to join the trial?

The trial requires that you stop taking certain medications before starting, such as immunotherapy, monoclonal antibodies, and skin-directed therapies. There are specific timeframes for stopping these treatments, like 28 days for systemic therapies and 14 days for skin-directed therapies. It's best to discuss your current medications with the trial team to see if they need to be paused.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that durvalumab is generally safe for people. This lab-made protein helps the immune system fight cancer. Studies suggest it is safe for treating various cancers, though side effects can occur. Serious side effects are rare.

When combined with lenalidomide, research indicates this combination is also safe for patients with certain advanced T-cell lymphomas. Most patients in these studies tolerated the treatment well, with side effects usually mild to moderate.

Since this trial uses both treatments together, ongoing research focuses on understanding any side effects and determining the best dose. Safety remains a top priority, and researchers work to ensure the treatment is as safe as possible for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for T-cell lymphoma because they offer novel approaches compared to standard chemotherapy options. Durvalumab is an immune checkpoint inhibitor that works by unleashing the immune system to attack cancer cells, which is different from traditional treatments that directly kill cancer cells. Adding lenalidomide, an oral medication known to modulate the immune system and inhibit cancer cell growth, could enhance this effect. This combination could potentially provide a more effective and targeted treatment, with the possibility of fewer side effects than conventional therapies.

What evidence suggests that this trial's treatments could be effective for T-cell lymphoma?

Research has shown that durvalumab, a type of medicine, can help stop cancer cells from growing and spreading. Studies have found it to be safe and effective for various types of cancer. In this trial, participants will receive either durvalumab alone or in combination with another medicine, lenalidomide. Early results suggest that the combination works even better for treating T-cell lymphoma, leading to long-lasting improvements in challenging cases. The side effects are manageable, making it a promising option for patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Christiane Querfeld, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for patients with relapsed or refractory cutaneous or peripheral T cell lymphoma. Eligible participants must have confirmed mycosis fungoides (MF) or Sezary syndrome (SS), measurable disease, and adequate organ function. They should not have had certain treatments recently and must be willing to use birth control. Exclusions include prior stem cell transplantation, active infections like HIV, unstable heart disease, severe allergies to similar drugs, and other conditions that could affect safety.

Inclusion Criteria

I have recovered from side effects of previous treatments, except for hair loss.

I am a woman who can have children and my pregnancy test is negative.

My condition is confirmed as mycosis fungoides or Sezary syndrome, and it's at an advanced stage.

Exclusion Criteria

Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

I am currently being treated for a serious infection.

I do not have a stomach or bowel condition that affects how my body absorbs medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive durvalumab with or without lenalidomide. Treatment repeats every 28 days for up to 13 courses.

12 months

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Durvalumab
• Lenalidomide

Trial Overview The trial is testing the effectiveness of durvalumab alone versus in combination with lenalidomide in treating T cell lymphoma that has returned after treatment. Durvalumab is a monoclonal antibody that may block cancer growth by targeting specific cells, while lenalidomide can stop cancer cells from growing by various mechanisms.

How Is the Trial Designed?

Group I: Arm II (durvalumab, lenalidomide) Experimental Treatment 3 Interventions

Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (durvalumab) Experimental Treatment 2 Interventions

Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6038862/

Safety and efficacy of durvalumab (MEDI4736) in various ... Durvalumab is safe in patients with many solid cancers and, in combination with tremelimumab, it has a tolerable safety profile and is associated with improved ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03011814?term=NCT03011814&rank=1

Durvalumab With or Without Lenalidomide in Treating ... Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma. TERTIARY OBJECTIVES: I.

3. ashpublications.org ashpublications.org/bloodadvances/article/9/9/2247/535589/Phase-1-trial-of-durvalumab-anti-PD-L1-combined

Phase 1 trial of durvalumab (anti–PD-L1) combined with ... Durvalumab plus lenalidomide has an acceptable safety profile with durable responses in refractory/advanced CTCL in a phase 1 study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12088755/

Phase 1 trial of durvalumab (anti–PD-L1) combined with ... Durvalumab plus lenalidomide has an acceptable safety profile with durable responses in refractory/advanced CTCL in a phase 1 study.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03003520

A Study of Durvalumab in Combination With R-CHOP or ... This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, and predictive biomarkers of durvalumab in combination with ...

6. esmoopen.com esmoopen.com/article/S2059-7029(24)00556-8/fulltext

215TiP A phase II study of durvalumab (MEDI 4736) ... DURVALUNG study aims to evaluate the efficacy of durvalumab maintenance specifically in frail LD-SCLC pts who have not progressed following concomitant or ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02617277

Study Details | NCT02617277 | Safety, Tolerability and ... This study will assess the safety, tolerability, and pharmacokinetics of AZD1775 (adavosertib) given orally in combination with intravenous MEDI4736 (durvalumab) ...

8. imfinzihcp.com imfinzihcp.com/nsclc/metastatic/safety.html

IMFINZI® (durvalumab) Safety and Adverse Reactions ... Review the safety data of IMFINZI® (durvalumab) with IMJUDO® (tremelimumab-actl) and chemotherapy for adults with metastatic non-small cell lung cancer.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02733042

NCT02733042 | A Study to Determine Dose, Safety, and ... A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic ...